An observational study in HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus) and Hepatitis C Virus (HCV), sponsored by Gardiens de Vies. Not yet recruiting. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Gardiens de Vies · Observational
Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from pregnant women attending antenatal care (ANC) services in the Democratic Republic of the Congo. This study aligns with the WHO 2022-2030 strategy for the integrated elimination of mother-to-child transmission of HIV, HBV, HCV, and syphilis.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 7,500 is above the median of 365 across 251 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →This is the only study on the registry with Gardiens de Vies as lead sponsor.
Compared within Hepatitis B, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Pregnant women attending antenatal care clinics among the 20 health facilities included for this study in DRCongo.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: for pregnant minors, the consent of a parent or legal guardian is required;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MagiA H3S : Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
Compare the sensitivity and specificity of the MAGIA H3S test with laboratory reference tests (ELISA/EIA for HIV, HBV and HCV, and syphilis) for detecting the following four markers in Congolese pregnant women: anti-HIV antibodies, anti-HCV antibodies, HBsAg and treponemal antibodies for syphilis.
Time frame: Baseline
Positive predictive value (PPV) and negative predictive value (NPV) of MagiA H3S device
NPV and PPV calculated for each of the four diseases, using the laboratory tests as the reference for the entire population and according to different geographical area and socio-demographic context.
Time frame: Baseline
Sensitivity and specificity of MagiA H3S device to dignose HIV, HBV, HCV and syphilis.
For each of the four diagnoses, the Sensitivity and specificity of the MAGIA H3S will calculated and compared to the sensitivity and specificity of RDTs test, using fourth generation ELISA as the reference.
Time frame: Baseline
Stratum-specific sensitivity and specificity of the H3S test.
For each of the four diagnoses, the sensitivity and specificity of the MagIA H3S device will be calculated by stratifying them according to known infection and/or treatment history.
Time frame: Baseline
SE and SP, PPV and NPV of the MagIA TREATB test among pregnants women.
Performance evaluation of MagiA TREATB test in detection of HbeAg, ALT and HbsAg quantification among pregnant women. The MagiA TREAT-B test that detect the Hbe-Ag, the ALT level and quantifies HbsAg will be compared to the laboratory tests as the reference.
Time frame: Up to 4 weeks
Se and Sp of the MagIA TREAT-B test in postpartum women, 6 months after delivery
Performance evaluation of MagiA TREATB test in detection of HbeAg, ALT and HbsAg quantification women who gave birth. The MagiA TREAT-B test that detect the Hbe-Ag, the ALT level and quantifies HbsAg will be compared to the laboratory tests as the reference.
Time frame: 6 month post partum
Number and types of usage errors observed during the study as well as any malfunctions of the MagiA H3S device.
Time frame: Baseline
Cotation of usability of the MagiA device from the users' perspective.
System usability scale will be used to assess the usability of use of the MagiA H3S test from healthcare personnel who have used the diagnostic tests. The score's scale ranges from 1 to 5. 1 means strongly disagree and 5 strongly agree.
Time frame: From baseline
Prevalence of HIV, hepatitis B and C viruses, and syphilis among pregnant women in the DRC.
Prevalence of HIV, HBV, HCV and Syphilis using laboratory tests results of pregnant women in DRC.
Time frame: Up to 4 weeks from baseline
Proportion of pregnant women who accepted the antenatal screening of HIV, HBV, HCV and Syphilis
The number of pregant women who accepted antenatal screening (rapid diagnostic tests and MagiA H3S) to detect HIV, HBV, HCV, and syphilis compared to total number of pregnant women attending antenatal services.
Time frame: Baseline
Proportion of positive results returned to pregnant women attending prenatal clinics in selected sites in the DRC.
Number of positive test results for HIV, HBV, HCV and Syphilis communicated to pregnant women who tested positive during antenatal consultations.
Time frame: Baseline
Cotation of Treatment adherence among positive pregnant women recieving treatment
Treatment adherence of study participants receiving treatment will be assessed at each follow-up visit using the 8-item Morisky Medication Adherence Scale. The Morisky adherence scale yields a score ranging from 0 to 8, with higher scores indicating better adherence to treatment.
Time frame: Through study completion, an average of 2 year
Proportion of vaccinated newborn born from positive HBV positive pregnants women within the first 24 hours.
Rate of newborns of pregnant women infected with HBV who received the hepatitis B vaccine
Time frame: At delivery
Rate of mother-to-child transmission for HIV, syphilis, HCV, and HBV.
For each of the four infections: ratio between number of newborns born to positive pregnant women and number of positive newborns is calculated
Time frame: Four to six weeks after birth for HIV, Six months after birth for HBV, at birth for syphilis and six weeks to tree months after birth for HCV post partum
Cost-effectiveness of the MAGIA H3S diagnostic test
Medical-economic evaluation of the MAGIA H3S diagnostic test by analyzing the costs associated with its implementation and its cost-effectiveness, compared to the absence of screening in routine antenatal care (status quo), and with the implementation of rapid HIV, HBV, HCV, and syphilis tests.
Time frame: Perioperative/Periprocedural
Cost-effectiveness of the MAGIA TREAT B diagnostic test to identify pregnant women eligible for antiviral prophylaxis against hepatitis B
* Total economic cost of introducing the MAGIA TREAT B test to identify pregnant women eligible for antiviral prophylaxis against Hepatitis B. * Cost-effectiveness assessment of the MAGIA TREAT B test, compared to the status quo and to viral load quantification or the HbeAg test.
Time frame: Perioperative/Periprocedural
Cost-effectiveness of the MAGIA TREAT B diagnostic test to identify women infected with hepatitis B virus who are eligible for long-term treatment for their own health
* Total economic cost of introducing the MAGIA TREATB test to identify women infected with hepatitis B virus who are eligible for long-term treatment for their own health * Cost-effectiveness assessment of the MAGIA TREAT B test, compared to the status quo, as well as to the use of the APRI score, or the measurement of viral load and/or ALT levels.
Time frame: through study completion, an average of 2 years.
Odds of pregnant women's preference regarding HBV diagnostic strategy for antenatal prophylaxis.
Preference estimated as odd ratio from a discrete choice experiment.
Time frame: One month after inclusion
Cotation of the capacity of health facilities to provide essential hepatitis care services
Health facility service availability and readiness will be presented as percentage ranging from 0% to 100% for included indicators using the WHO's Service Availability and Readiness Assessment (SARA) tool. The study will describe the percentage of service availability and readiness for each health facility.
Time frame: 1 to 2 months before the begining of the study
No study locations are listed for this record.
Plan to share: Yes — The IPD from this research will be shared upon written request by contacting the project coordinator, the president of MAGIA Diagnostics, and the study sponsor, the coordinator of GArdiens de Vies, at the following email addresses: paul.kauffmann@magia-diagnostics.com and olivier.kana@gardiensdevies.org
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From the end of the study up to 5 years later
Access criteria: Researcher must write a request by contacting the project coordinator, the president of MAGIA Diagnostics, and the study sponsor, the coordinator of GArdiens de Vies, at the following email addresses: paul.kauffmann@magia-diagnostics.com and olivier.kana@gardiensdevies.org
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Dec 2026, 9 months later.
Of 69 non-industry observational studies under Hepatitis B, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 126. This study's planned 9 months is below that.
Counting every sponsor, half of 81 studies reached it within 55 months; a quarter within 17 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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